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Specific Oral Tolerance Induction to Cow's Milk Allergy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01199484
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : September 13, 2010
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Brief Summary:

Background: Limited published evidence shows specific oral tolerance induction (SOTI) to be a potential intervention option for cow's milk proteins (CMPs) allergy. Our hypothesis is that SOTI should be started early in order to improve its efficacy and prevent CMPs sensitization from evolving towards persistent allergy. The aim of this study was to evaluate the safety and efficacy of SOTI in 2-year-old children with cow's milk allergy, as a treatment alternative to elimination diet.

Methods: A total of 60 children between 24-36 months of age with IgE-mediated allergy to CMPs were included in this multicenter study and were randomly divided into two different groups. Thirty children (group A: treatment group) began SOTI immediately, whereas the remaining 30 (group B: control group) were kept on a milk-free diet and followed-up on for one year.

Condition or disease Intervention/treatment Phase
Food Hypersensitivity Other: Cow's milk Not Applicable

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Study Type : Interventional  (Clinical Trial)
Official Title: Specific Oral Tolerance Induction as an Useful Treatment in Two-year-old Children With Cow's Milk Allergy.

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Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. -Infants between 24-36 months of age.
  2. -IgE-mediated allergy to CMPs meeting all the following diagnostic criteria:

    • Immediate-type clinical manifestations, skin (urticaria, angioedema and/or erythema), digestive (acute vomiting and/or diarrhea) or respiratory (bronchospasm and/or rhinitis) involvement in the first two hours after cow's milk ingestion.
    • Skin test readings ≥ 3 mm and specific IgE titers > 0.35 kU/l for whole cow's milk or someone of isolated CMPs (casein, alpha-lactalbumin, beta-lactoglobulin )
  3. -Persistence of CMP allergy in the four weeks prior to tolerance induction, based on the following criteria:

    • Skin (prick) test readings ≥3 mm and specific IgE titers (CAP-FEIA) >0.35 kU/l for whole cow's milk or someone of isolated CMPs (casein, alpha-lactalbumin, beta-lactoglobulin )
    • Double-blind placebo-controlled challenge (DBPCFC) positive to cow's milk.
  4. -Written informed consent from the parents.

Exclusion Criteria:

  1. -Clinical manifestations of anaphylactic shock after the ingestion of cow's milk.
  2. -Non-IgE-mediated or non-immunological adverse reactions to cow's milk.
  3. -Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
  4. -Patients receiving immunosuppressor therapy.
  5. -Patients receiving beta-blockers (including topical formulations).
  6. -Associated diseases contraindicating the use of adrenalin: cardiovascular disease or severe hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01199484

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Allergy Unit. University General Hospital
Valencia, Spain, 46014
Sponsors and Collaborators
Valencia University General Hospital

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Responsible Party: Antonio Martorell Aragones, Allergy Unit. University General Hospital Identifier: NCT01199484     History of Changes
Other Study ID Numbers: SOTI-CMA
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: September 13, 2010
Last Verified: September 2010
Keywords provided by ValenciaUGH:
Cow's milk allergy
food allergy
oral desensitization
randomized trial
specific oral tolerance induction.
Additional relevant MeSH terms:
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Milk Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate